Cleared Traditional

K940375 - MICRO MPM

K940375 is an FDA 510(k) clearance for MICRO MPM, manufactured by Micro Direct, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K940375 · Micro Direct, Inc. · Anesthesiology device
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Nov 1994
Decision
299d
Days
Class 2
Risk

K940375 is an FDA 510(k) clearance for the MICRO MPM. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 299 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K940375

510(k) Number K940375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date November 21, 1994
Days to Decision 299 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 140d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 58
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K940375.
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · Mercury Medical · Apr 1996
AMS 3000M
K936009 · Acutronic Medical Systems AG · May 1995
PORTA-RESP MONITOR
K943146 · S & M Instrument Co. · Nov 1994
CM7000 REMOTE INDICATOR
K931287 · Canadian Monaghan , Ltd. · Jul 1993
CM5000R REMOTE INDICATOR
K931394 · Canadian Monaghan , Ltd. · Jul 1993
AIRWAY PRESSURE MONITOR CM 5000 NGAN
K925673 · Canadian Monaghan , Ltd. · Jun 1993
K940375 · MICRO MPM
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